Diclofenac Sodium

Product NDC
68682-103
11-digit product format
686820103
Labeler code
68682
Product ID
68682-103_303dda9b-8a02-68c8-e063-6294a90a2d5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
ANDA075492
Marketing category
ANDA
Marketing start
2000-02-28
Substance
DICLOFENAC SODIUM
Active strength
100 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075492-001DICLOFENAC SODIUMDICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A075492-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-113f01610625f2…
2019-09-15 20:21 UTC2019-09A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075492-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075492-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075492-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075492-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075492-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075492-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075492-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075492-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075492-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075492-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075492-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075492-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075492-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075492-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075492-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075492-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075492-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075492-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075492-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075492-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075492-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075492-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075492-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075492-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075492-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075492-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075492-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075492-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075492-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075492-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075492-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075492-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075492-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075492-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075492-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075492-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075492-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075492-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075492-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075492-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855657Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c48113e0-9f1e-4086-b18f-3204c0d2a689Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-103-01Diclofenac Sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-103-01EA - Each68682-103cddf5690-7361-43b8-8878-34825d0da3cc12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-103DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]9Current NDC, Legacy NDC, 1 package rows20250316_c48113e0-9f1e-4086-b18f-3204c0d2a689.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMOceanside Pharmaceuticalsc48113e0-9f1e-4086-b18f-3204c0d2a6892025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492
ndc (product): 68682-103
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPd70fcd8e-a72b-41ef-ac26-e0f2f279f0622025-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack49013aad-475c-4efb-84c6-15a5d4664fbf2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492
Diclofenac Sodium ERDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCecaa39b8-067c-80d7-e053-2a95a90a73542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.abacf60f-0410-e6da-e053-2995a90a413c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsd9698809-4887-4514-aa28-0066355ef9082023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNd9698809-4887-4514-aa28-0066355ef90810
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDd9698809-4887-4514-aa28-0066355ef90810
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYd9698809-4887-4514-aa28-0066355ef90810
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNc48113e0-9f1e-4086-b18f-3204c0d2a6899
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDc48113e0-9f1e-4086-b18f-3204c0d2a6899
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYc48113e0-9f1e-4086-b18f-3204c0d2a6899
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN49013aad-475c-4efb-84c6-15a5d4664fbf6
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD49013aad-475c-4efb-84c6-15a5d4664fbf6
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY49013aad-475c-4efb-84c6-15a5d4664fbf6
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNd70fcd8e-a72b-41ef-ac26-e0f2f279f0624
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN85ba4872-19db-2316-e053-2991aa0a00fc4
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNecaa39b8-067c-80d7-e053-2a95a90a73544
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDd70fcd8e-a72b-41ef-ac26-e0f2f279f0624
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD85ba4872-19db-2316-e053-2991aa0a00fc4
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDecaa39b8-067c-80d7-e053-2a95a90a73544
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYd70fcd8e-a72b-41ef-ac26-e0f2f279f0624
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY85ba4872-19db-2316-e053-2991aa0a00fc4
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYecaa39b8-067c-80d7-e053-2a95a90a73544
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNabacf60f-0410-e6da-e053-2995a90a413c3
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDabacf60f-0410-e6da-e053-2995a90a413c3
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYabacf60f-0410-e6da-e053-2995a90a413c3
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNaeda6c4e-d6fe-4ca6-968f-96214ed48f2f2
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDaeda6c4e-d6fe-4ca6-968f-96214ed48f2f2
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYaeda6c4e-d6fe-4ca6-968f-96214ed48f2f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-103-0168682010301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-103-01) 2000-02-280000-00-00NoNoCurrent